{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "CAESAREA BUSINESS PARK", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "8200 CORAL SEA STREET NE MVS21", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "76352656", "event_type": "Injury", "report_number": "3005075696-2026-00028", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20260122", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20251209", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260122", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "206099", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260122", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Mechanical Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Use of Device Problem", "Communication or Transmission Problem", "Unintended Application Program Shut Down" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/21/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260421", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260211", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24148383", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260102", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30798", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAZOR ROBOTICS LTD", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "393194509", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE REPORTED ADVERSE EVENTS WERE RELATED TO THE GUIDANCE SYSTEM." }, { "mdr_text_key": "393194510", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2, B5: EVENT DETAILS HAVE BEEN UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "390950012", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MAITY, APRATIM, ET AL. ¿ANALYSIS OF ROOT CAUSES OF ADVERSE EVENTS WITH MAZOR X AND MAZOR X STEALTH EDITION-GUIDED SPINE SURGERIES: AN FDA MAUDE DATABASE STUDY.¿ EUROPEAN SPINE JOURNAL, 22 DEC. 2025, HTTPS://DOI.ORG/10.1007/S00586-025-09683-2. ABSTRACT PURPOSE: THIS STUDY AIMED TO ANALYZE ADVERSE EVENTS ASSOCIATED WITH MAZOR X SURGICAL GUIDANCE ROBOTS, FOCUSING ON PARAMETERS SUCH AS ROOT CAUSES, VERTEBRAL DISTRIBUTION, SURGICAL DELAY, ROBOT ABANDONMENT, AND MORE. METHODS: 330 ADVERSE EVENTS REPORTED WITHIN THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FOR THE MAZOR X (MX) AND MAZOR X STEALTH EDITION (MXSE) ROBOT GUIDANCE SYSTEMS WERE ANALYZED AND CATEGORIZED BASED ON THE ROOT CAUSES, VERTEBRAL DISTRIBUTION, SURGICAL DELAY, ROBOT ABANDONMENT, AND PATIENT OUTCOMES. RESULTS: BOTH THE MX AND MXSE ADVERSE EVENTS WERE PRIMARILY DUE TO EXTERNAL ROOT CAUSES (35% AND 52%, RESPECTIVELY), WITH USER ERROR BEING THE MOST COMMON. DEVIATIONS WERE MOST LIKELY TO AFFECT THE L3, L4, AND L5 VERTEBRA, AND DEVIATE EITHER MEDIALLY OR LATERALLY. MOTOR DEFICITS WERE THE MOST COMMON ADVERSE PATIENT OUTCOME FOR MX, WHILE SENSORY DEFICITS WERE THE MOST COMMON FOR MXSE. THERE WERE TWO DEATHS ASSOCIATED WITH THE MX, COMPARED TO ZERO DEATHS WITH THE MXSE. CONCLUSION: WHILE THE MAUDE DATABASE CANNOT BE USED TO CALCULATE THE INCIDENCE OR PREVALENCE OF ADVERSE EVENTS, IT PROVIDES INSIGHT INTO THE TYPES OF ADVERSE EVENTS THAT TEND TO OCCUR WITH MEDICAL DEVICES. MAUDE REPORTS SUGGEST THAT USER RELATED ERRORS ACCOUNT FOR MOST OF THE ADVERSE EVENTS THAT OCCUR, UNDERSCORING THE NEED FOR FOCUSED SURGEON TRAINING. OUR STUDY HIGHLIGHTS THE IMPORTANCE OF UNDERSTANDING BOTH THE TYPES OF ADVERSE EVENTS AND THEIR ROOT CAUSES TO PROMOTE PATIENT SAFETY AND REDUCE COMPLICATION RATES. REPORTED EVENTS: 79 DEVIATION EVENTS WERE IDENTIFIED. IN ADDITION, THERE WERE REGISTRATION ERRORS, SYSTEM ERRORS, NAVIGATION ERRORS, SPONTANEOUS REST ARTS AND MACHINE HARDWARE DEFECTS. IT WAS REPORTED THAT THE MOST COMMON ADVERSE PATIENT OUTCOME WERE SENSORY DEFICITS. ADDITIONALLY, 20% OF EVENTS REQUIRED REVISION SURGERY AND 28% HAD ABORTION OF THE SYSTEM. ROOT CAUSES OF THE DEVIATIONS, REGISTRATION ERROR, SYSTEM ERROR, NAVIGATION ERROR, AND MACHINE HARDWARE DEFECTS WERE ATTRIBUTED TO ANATOMY, SOFT TISSUE PRESSURE, USER ERROR, EXTERNAL MACH INE ERRORS, PATIENT SHIFTS, SURGICAL ARM ISSUES, CT-FLUORO REGISTRATION, AND NAVIGATION." }, { "mdr_text_key": "390950015", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE ACCEPTED PUBLICATION DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/11/2026" } ] }